Apparatus and method for hydrating a particulate biomaterial with a liquid biomaterial

ABSTRACT

An apparatus and method for hydrating a particulate biomaterial with a liquid biomaterial includes a vacuum device and a valve for withdrawing a gas from the particulate biomaterial and introducing the liquid biomaterial. The valve includes a hub, a valve body, a particulate port, a vacuum port, and a liquid port. The valve body selectively moves between first and second positions. The valve body at least partially defines a first passage and a second passage. The particulate port, the vacuum port, and the liquid port are each configured to fluidly connect to a particulate container, the vacuum device, and the liquid container, respectively. In the first position, the first passage fluidly connects the vacuum port to the particulate port for withdrawing the gas from the particulate container. In the second position, the second passage fluidly connects the liquid port to the particulate port for hydrating the particulate biomaterial.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the priority of Application Ser. No. 61/794,743filed Mar. 15, 2013, the disclosure of which is hereby incorporated byreference herein.

TECHNICAL FIELD

The present invention relates generally to an apparatus and method forhydrating a particulate biomaterial with a liquid biomaterial, and moreparticularly, to an apparatus and method for hydrating a bone graftparticulate material with a liquid bone graft biomaterial.

BACKGROUND

Bone grafting is a surgical procedure for repairing bones and typicallyinvolves introducing a mixture of particulate, such as bone graftmaterial, into an area of bone that requires repair, such as a fracture.The bone graft material is intended to stimulate growth of healthynative bone tissue, and new native bone tissue may eventually replacethe bone graft material completely. Bone graft material is a type ofbiomaterial and typically includes a combination of crushed bone and aliquid component, such as blood, plasma, or growth factors. Bone graftmaterials can be allograft (derived from a human other than the onereceiving the graft), autograft (derived from the human receiving thegraft), and synthetic (created from, for example, ceramics like calciumphosphates).

Bone graft materials are typically delivered to a surgical site usingsyringe-like delivery devices, which often include attachments, such assmall diameter cannulae. In addition, the components of the bone graftmaterial are sometimes brought together and combined to form the mixtureof the bone graft material in the delivery device. However, the mixtureof the bone graft material tends to also include gas from the porosityof the crushed bone and the aeration associated with mixing thecomponents. As the bone graft materials dry after being applied to thesurgical site, a portion of the gas collects into pockets within thesetting bone graft material. The pockets create inconsistencies in thefinal bone graft material that may result in performance variationthroughout the bone graft material.

Furthermore, hydrating the particulate biomaterial with the liquidbiomaterial requires additional time for the liquid biomaterial todisplace the gas and disperse throughout the entirety of the particulatebiomaterial. At the very least, this additional time increases the costof the medical procedure. In addition, a relatively fine particulatebiomaterial tends to non-uniformly absorb the liquid component, whichrequires additional blending to mix the particulate and liquidbiomaterial to a generally uniform mixture.

There is a need for an apparatus and method for hydrating a particulatebiomaterial with a liquid biomaterial, such as a particulate and liquidbone graft materials, that reduces the gas within the mixture andaddresses present challenges and characteristics such as those discussedabove.

SUMMARY

An exemplary embodiment of an apparatus for hydrating a particulatebiomaterial with a liquid biomaterial includes a vacuum deviceconfigured to generate a vacuum and a valve for withdrawing a gas fromthe particulate biomaterial and introducing the liquid biomaterial tothe particulate biomaterial. The valve includes a hub, a valve body, aparticulate port, a vacuum port, and a liquid port. The valve body ismovably coupled with the hub and configured to selectively move betweena first position and a second position. The valve body at leastpartially defines a first passage and a second passage. The particulateport is configured to fluidly connect to a particulate container holdingthe particulate biomaterial therein. The vacuum port is configured tofluidly connect to the vacuum device such that the first passage fluidlyconnects the vacuum port to the particulate port when the valve body isin the first position for withdrawing the gas from the particulatecontainer. The liquid port is configured to fluidly connect to a liquidcontainer holding the liquid biomaterial therein. As such, the secondpassage fluidly connects the liquid port to the particulate port whenthe valve body is in the second position for withdrawing the liquidbiomaterial from the liquid container, through the second passage, andto the particulate container for hydrating the particulate biomaterial.

An exemplary embodiment of a valve for withdrawing a gas from aparticulate biomaterial and introducing a liquid biomaterial to theparticulate biomaterial includes a hub, a valve body, a particulateport, a vacuum port, and a liquid port. The valve body is movablycoupled with the hub and configured to selectively move between a firstposition and a second position. The valve body at least partiallydefines a first passage and a second passage. The particulate port isconfigured to fluidly connect to a particulate container holding theparticulate biomaterial therein. The vacuum port is configured tofluidly connect to the vacuum device such that the first passage fluidlyconnects the vacuum port to the particulate port when the valve body isin the first position for withdrawing the gas from the particulatecontainer. The liquid port is configured to fluidly connect to a liquidcontainer holding the liquid biomaterial therein. As such, the secondpassage fluidly connects the liquid port to the particulate port whenthe valve body is in the second position for withdrawing the liquidbiomaterial from the liquid container, through the second passage, andto the particulate container for hydrating the particulate biomaterial.

In use, a method of hydrating a particulate biomaterial with a liquidbiomaterial to form a mixture of biomaterials includes a vacuum deviceand a valve. The particulate biomaterial is held within a particulatecontainer and the liquid biomaterial is held within a liquid container.The valve is fluidly connected to the particulate container, the liquidcontainer, and the vacuum device. The valve has a valve body selectivelymovable between a first position and a second position. The methodincludes generating a vacuum within the particulate container with thevacuum device when the valve body is in the first position. The methodalso includes withdrawing a gas from the particulate container andthrough the valve body toward the vacuum device to maintain the vacuumwithin the particulate container. In addition, the method includesmoving the valve body to the second position such that the liquidcontainer fluidly connects to the particulate container via the valvebody. The method further includes releasing the vacuum within theparticulate container to the liquid container to withdraw the liquidbiomaterial from the liquid container and introduce the liquidbiomaterial into the particulate container. The method also includeshydrating the particulate biomaterial with the liquid biomaterial toform the mixture of biomaterials.

Various additional objectives, advantages, and features of the inventionwill be appreciated from a review of the following detailed descriptionof the illustrative embodiments taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention and,together with a general description of the invention given above, andthe detailed description given below serve to explain the invention.

FIG. 1 is a perspective view of an embodiment of an apparatus having afirst embodiment of a valve for hydrating a particulate bone graftmaterial with a liquid bone graft material.

FIG. 2 is perspective view of the valve of FIG. 1.

FIG. 3 is a cross-section view of FIG. 1.

FIG. 4A is an enlarged cross-section view similar to FIG. 3 with thevalve having a valve body in a first position for withdrawing a gas froma particulate container.

FIG. 4B is a cross-section view similar to FIG. 4A, but showing theshowing the gas being discharged to the ambient environment.

FIG. 4C is a cross-section view similar to FIG. 4B, but showing thevalve body in a second position for introducing the liquid bone graftmaterial into the particulate container.

FIG. 5 is a perspective view of a second embodiment of a valve forhydrating a particulate bone graft material with a liquid bone graftmaterial.

FIG. 6A is a cross-section of the valve of FIG. 5 having a valve body ina first position for withdrawing a gas from a particulate container.

FIG. 6B is a cross-section view similar to FIG. 6A, but showing theshowing the gas being discharged to the ambient environment.

FIG. 6C is a cross-section view similar to FIG. 6B, but showing thevalve body in a second position for introducing the liquid bone graftmaterial into the particulate container.

FIG. 7 is a cross-section view of the valve taken along section line 7-7of FIG. 6C.

FIG. 8A is a cross-section of a third embodiment of a valve forhydrating a particulate bone graft material with a liquid bone graftmaterial in which the valve has a valve body in a second position.

FIG. 8B is a cross-section view similar to FIG. 7A, but showing thevalve having a valve body in a first position for withdrawing a gas froma particulate container.

FIG. 8C is a cross-section view similar to FIG. 7B, but showing thevalve body in the second position for introducing the liquid bone graftmaterial into the particulate container.

DETAILED DESCRIPTION

With reference to FIGS. 1-3, a first embodiment of an apparatus 10 forhydrating a particulate biomaterial with a liquid biomaterial includes avalve 16 fluidly connected to a vacuum device 18, a particulatecontainer 20, and a liquid container 22. The particulate container 20holds the particulate biomaterial, while the liquid container 22 holdsthe liquid biomaterial. The valve 16 includes a valve body 24 movablycoupled with a hub 26 and, as such, selectively moves between a firstposition and a second position. According to an exemplary embodiment,the hub 26 includes a particulate port 27 and an opposing liquid port28, both of which are configured to removably connect to the particulatecontainer 20 and liquid container 22, respectively. The valve body 24includes a vacuum port 30 configured to removably connect to the vacuumdevice 18 for generating a vacuum therein. In the first position, thevacuum device 18 is configured to withdraw a gas from the particulatebiomaterial, while the valve 16 maintains the vacuum within theparticulate container 20. Once a desirable amount of the gas is removedfrom the particulate container 20, a practitioner, such as a doctor,nurse, or similarly trained medical professional, selectively moves thevalve body 24 to the second position, which fluidly connects theparticulate container 20 to the liquid container 22. In turn, the valve16 operatively releases the vacuum to the liquid container 22 andwithdraws the liquid biomaterial into the particulate container 20 forhydrating the particulate biomaterial therein. As described herein, theparticulate and liquid biomaterial may be any biomaterial component,such as dry particulate component and/or a liquid biomaterial component,respectively. According to an exemplary embodiment, the particulatebiomaterial is a dry bone graft biomaterial component, such as anallograft, autograft, or synthetic biomaterial material, and the liquidbiomaterial is a bone graft biomaterial component, such as blood,plasma, or growth factors. However, it will be appreciated that theapparatus 10 may be used to hydrate any particulate material with aliquid material and is not intended for use only with bone graftbiomaterials.

According to an exemplary embodiment, the vacuum device 18 is in theform of a syringe 32 including a syringe body 34 and a plunger 36. Thegenerally cylindrical syringe body 34 defines a cavity 38 extendingtherethrough, which slidably receives the plunger 36 through a distalopening 39. The syringe 32 also includes a proximal opening 40 (see FIG.4A) in fluid communication with the vacuum port 30. With respect to theuse of the terms “distal” and “proximal,” it will be appreciated thatsuch directions are intended to describe relative locations alongexemplary embodiments of the apparatus 10. More particularly, the term“distal” refers to relative positions away from the valve 16, whereasthe term “proximal” refers to relative positions near the valve 16. Itis not intended that the terms “distal” and “proximal” limit theinvention to any of the exemplary embodiments described herein.Furthermore, the particulate container 20 and liquid container 22 arealso in the form of syringes 32 that similarly include additionalsyringe bodies 34 and plungers 36. However, it will be appreciated thatany vacuum device 18 and containers for holding particulate and liquidbiomaterial may be similarly used. By way of example, one or both of theparticulate and liquid containers 20, 22 may alternatively be in theform of a collapsible container, such as a sealable bag. As such, it isnot intended to limit the vacuum device 18, the particulate container20, and the liquid container 22 to the embodiments described herein.

The syringe body 34 is generally transparent for viewing any contentswithin the cavity 38. Of course, it will be appreciated that the syringe32 may alternatively be translucent for viewing the contents therein.Each of the particulate, liquid, and vacuum ports 27, 28, 30 includes acoupling 42, which may be in the form of a male coupling 42. Inaddition, the syringe 32 also includes female coupling 44 thatcooperates with the male couplings 42 for fluidly connecting eachsyringe 32 to the valve 16 via a hole 45 extending proximally from thesyringe body 34 toward the valve body 24. According to an exemplaryembodiment, the male and female couplings 42, 44 are in the form of maleand female luer couplings, respectively. However, it will be appreciatedthat any structure for fluidly connecting the vacuum device 18, theparticulate container 20, and the liquid container 22 to the valve 16may be similarly used.

As described briefly above and with respect to FIG. 1 and FIG. 4A, thevalve 16 includes the valve body 24 selectively movable between thefirst position and the second position relative to the hub 26. The hub26 surrounds a portion of the valve body 24 such that vacuum port 30projects distally from the hub 26 and toward the vacuum device 18. Moreparticularly, the hub 26 defines an aperture 48 that receives andcaptures the valve body 24 and defines a particulate bore 50 and aliquid bore 52, both of which extend through the hub 26 generallytransverse to the aperture 48. The particulate bore 50 extends from theparticulate port 27 to the aperture 48, and the liquid bore 52 similarlyextends from the liquid port 28 to the aperture 48. While the valve body24 is captured within the hub 26, the valve body 24 is still free torotate a first direction, as indicated by arrow 53, toward the firstposition and a second direction toward the second position. According toan exemplary embodiment, the first direction is clockwise and the seconddirection is counterclockwise. However, these exemplary directions arenot intended to limit the invention described herein.

To inhibit leakage between the hub 26 and the valve body 24 and into theaperture 48, an exemplary embodiment of the hub 26 also includes aplurality of annular recesses 54 a, 54 b, 54 c that cooperates with aplurality seals 56 a, 56 b, 56 c. The annular recesses 54 a, 54 bgenerally surround the particulate and liquid bores 50, 52,respectively, and extend to the aperture 48 within the hub 26. Theannular recess 54 c is generally transverse to the annular recess 54 a,54 b and surrounds the valve body 24 within the aperture 48. As such,the annular recesses 54 a, 54 b, 54 c receive the seals 56 a, 56 b, 56 cfor sealing the particulate, liquid, and vacuum ports 27, 28, 30 fromeach other and inhibiting the vacuum, the particulate biomaterial, andthe liquid biomaterial from leaking into the aperture 48 and/or into theambient environment. It will be appreciated that the valve body 24 maymove between the first and second positions by rotating, as discussedfurther below, or by any other movement. For example, the valve body 24may alternatively linearly translate as will be described later infurther detail. The following will address additional structure of thevalve body 24 with respect to the first position and the secondposition.

FIG. 4A shows the apparatus 10 having the valve body 24 in the firstposition. The valve body 24 extends along a rotational axis 60 andincludes a distal opening 62 that opens into the vacuum port 30.Specifically, the vacuum port 30 extends along and parallel to therotational axis 60. The valve body 24 further defines a first conduit 64that extends from the vacuum port 30 to the particulate bore 50 forfluid communication with the particulate port 27. As such, the vacuumport 30 and the particulate port 27 are fluidly connected only when thevalve body 24 is in the first position. As discussed above, the valvebody 24 is already in the first position and, as such, the vacuum port30, the first conduit 64, the particulate bore 50, and the particulateport 27 collectively define a first passage 65 extending from the vacuumdevice 18 to the particulate container 20. However, in the event thatthe valve body 24 is not in the first position, the hub 26 includes afirst abutment member 66 projecting distally toward the valve body 24that cooperates with a first stop surface 68 for positioning the valvebody 24. More particularly, the valve body 24 rotates the clockwisedirection 53 (see FIG. 1) until the first stop surface 68 contacts thefirst abutment member 66 such that the first conduit 64 rotatably alignsto fluidly connect to the particulate port 27 and define the firstpassage 65.

Once the vacuum port 30 is fluidly connected to the particulate port 27via the first conduit 64, the plunger 36 is withdrawn within the syringebody 34 of the vacuum device 18, as indicated by arrow 70 and alsoreferred to herein as a vacuum stroke 70. In turn, the vacuum device 18generates a vacuum, which withdraws the gas from the particulatecontainer 20, as indicated by arrows 72. A first check valve 74 is alsopositioned within the first passage 65 for inhibiting the gas fromreturning to the particulate container 20. The first check valve 74 ismounted within the first conduit 64 of the valve body 24. At thisposition, the first check valve 74 is operable to open and close by thepressure differential between the vacuum port 30 and particulate port27. In the event that the pressure in the vacuum port 30 is less thanthe pressure in the particulate port 27, the first check valve 74selectively opens for withdrawing gas from the particulate container 20.However, in the event that the pressure in the vacuum port 30 is greaterthan the pressure in the particulate port 27, the first check valve 74selectively closes for effectively sealing the first conduit 64 closedand inhibiting the gas from returning to the particulate container 20.Thus, even if the practitioner halts the vacuum stroke 70, the vacuum ismaintained within the particulate container 20.

According to an exemplary embodiment, the plunger 36 of the vacuumdevice 18 may reverse direction to reset the plunger 36 for anadditional vacuum stroke 70 to generate additional vacuum within theparticulate container 20. The reverse direction is also referred toherein as a pressure stroke and is indicated by arrow 76 in FIG. 4B. Tocomplete the pressure stroke 76 without forcing the gas back into theparticulate container 20, the valve body 24 further includes a ventconduit 78 extending from the first conduit 64 to the ambientenvironment and a second check valve 80 to release excess pressure fromthe first passage 65. The second check valve 80 is fluidly connected tothe first passage 65 and, more particularly, is mounted within the ventconduit 78 that opens into the first conduit 64. At this position, thesecond check valve 80 is operable to open and close by the pressuredifferential between the vacuum port 30 and the ambient environment. Inthe event that pressure in the vacuum port 30 is less than an ambientpressure in the ambient environment, the second check valve 80selectively closes for sealing the first conduit 64 from the ambientenvironment. However, in the event that the pressure in the vacuum port30 is greater than the ambient pressure, the second check valve 80selectively opens for releasing excess pressure from the first passage65 to the ambient environment, as indicated by arrow 81. By way ofexample, the first and second check valves 74, 80 are duckbill checkvalves. However, it will be appreciated that generally any type of checkvalve may be used as described above. For example, the first and/orsecond check valve 74, 80 may alternatively be a mushroom check valve,an umbrella check valve, a ball check valve, a dome check valve, aflapper valve, or any other type of check valve for permittingone-directional flow. As such, the invention is not intended to belimited to the exemplary valves shown and described herein.

An exemplary embodiment shown in FIG. 4A and FIG. 4B generates thevacuum for withdrawing the gas from the particulate container 20 via theplunger 36 cooperating with the syringe body 34 of the vacuum device 18.The practitioner may select or manufacture the particulate biomaterial,such as the bone graft material, using known devices and methods andthen load the particulate container 20 with a desirable amount of theparticulate biomaterial.

During the vacuum stroke 70, the plunger 36 moves distally from thevalve 16, which, in turn, causes the volume of the cavity 38 proximal ofthe plunger 36 to increase. The increase in volume creates a decrease inpressure, otherwise referred to herein as the vacuum. The vacuum withinthe cavity 38 transfers to the first conduit 64 to simultaneously openthe first check valve 74 and close the second check valve 80. With thefirst check valve 74 open, the vacuum transfers through the firstconduit 64, the particulate bore 50, the particulate port 27 andthroughout the fluidly connected particulate container 20. Because theparticulate biomaterial and the gas within the particulate container 20are exposed to the vacuum, the gas is withdrawn from the particulatecontainer 20 through the first passage 65 and into to the increasingvolume of the vacuum device 18.

The vacuum may continue to increase within the particulate container 20so long as the plunger 36 of the vacuum device 18 moves distally throughthe vacuum stroke 70. Once the plunger 36 reaches the top of the vacuumstroke 70, the vacuum device 18 ceases to withdraw the gas from theparticulate container 20. As such, the pressure within the particulateport 27 is below the pressure within the vacuum port 30 causing thefirst check valve 74 to close and generally maintain the vacuum withinthe particulate container 20.

Once the plunger 36 is at the top of the vacuum stroke 70, the cavity 38may be purged of gas by manipulating the plunger 36 through the pressurestroke 76. Through the pressure stroke 76, the plunger 36 movesproximally toward the valve 16 through the cavity 38, which, in turn,causes the volume within the syringe body 34 to decrease. The decreasein volume creates an increase in pressure within the vacuum port 30 andthe first conduit 64. While the first check valve 74 remains closedduring the increase in pressure, the second check valve 80 opens withthe increase in pressure and raises above that of the ambientenvironment. As such, the gas within the cavity 38 is forced by theplunger 36 from the cavity 38, into the vent conduit 78, through thesecond check valve 80, and into the ambient environment. The gascontinues to purge from the cavity 38 until the plunger 36 reaches thebottom of the pressure stroke 76. The vacuum stroke 70 and pressurestroke 76 may be repeated to increase the vacuum within the particulatecontainer 20 as desired by the practitioner or as limited by the sealingcapabilities of the plunger 36, syringe body 34, and/or seals 56 a, 56b, 56 c. According to an exemplary embodiment, the vacuum device 18 is a5 milliliter syringe that generates a vacuum between 0 inHg and 25 inHg.More particularly, the vacuum device 18 generates a vacuum ofapproximately 20 inHg for withdrawing the gas from the particulatebiomaterial.

With a desirable vacuum generated within the particulate container 20,the practitioner selectively moves the valve body 24 to the secondposition to fluidly disconnect the first conduit 64 from the particulateport 27. The hub 26 includes a second abutment member 82 (see FIG. 2)projecting distally toward the valve body 24 that cooperates with asecond stop surface 84 (see FIG. 2) for positioning the valve body 24.More particularly, the valve body 24 rotates the counterclockwisedirection until the second stop surface 84 contacts the second abutmentmember 82, as indicated by arrow 85. Accordingly, a second conduit 86defined by the valve body 24 rotatably aligns to fluidly connect theparticulate port 27 to the liquid port 28 and define a second passage 88as shown in FIG. 4C. The second conduit 86 extends directly between theparticulate bore 50 and the liquid bore 52 such that the liquid port 28,the liquid bore 52, the particulate bore 50, and the particulate port 27collectively define the second passage 88 for introducing the liquidbiomaterial into the particulate container 20, as indicated by arrows90.

As discussed above and with reference to FIG. 3 and FIG. 4C, prior tomoving the valve body 24 to the second position, the particulatecontainer 20 contains the particulate biomaterial under the influence ofthe vacuum maintained therein. Thus, moving the valve body 24 to thesecond position releases the vacuum through the second passage 88 and tothe liquid container 22. Because the liquid container 22 has a variablevolume for containing the liquid biomaterial within the syringe body 34of the liquid container 22, the vacuum released to the liquid container22 collapses the variable volume and withdraws the liquid biomaterialfrom the liquid container 22, through the second passage 88, and intothe particulate container 20. In the event that the particulatebiomaterial is relatively porous, the vacuum tends to increase the rateof absorption of the liquid biomaterial within the particulatebiomaterial and more quickly hydrate the particulate biomaterial to forma mixture of biomaterials.

With reference to FIGS. 5-7, a second embodiment of an apparatus 210 forhydrating a particulate biomaterial with a liquid biomaterial includes avalve 216 fluidly connected to the vacuum device 18, a particulatecontainer 220, and a liquid container 222. The particulate container 220holds the particulate biomaterial, while the liquid container 222 holdsthe liquid biomaterial. In contrast with the previous embodiment, theliquid container 222 includes a female coupling 244, which cooperateswith a liquid port 228 having a male coupling 242, while the particulatecontainer 220 includes the male coupling 242 and a particulate port 227has the female coupling 244. With respect to the second embodiment ofthe apparatus 210, like numbers indicate like features discussed aboveand it will be appreciated that the above description similarly appliesto the apparatus 210.

The valve 216 includes a valve body 224 movably coupled with a hub 226and, as such, selectively moves between a first position and a secondposition. According to an exemplary embodiment, the hub 226 includes theparticulate port 227 and the opposing liquid port 228. The valve body224 includes a vacuum port 230 configured to removably connect to thevacuum device 18 for generating a vacuum therein. The hub 226 surroundsa portion of the valve body 224 such that vacuum port 230 projectsdistally from the hub 226 and toward the vacuum device 18. Moreparticularly, the hub 226 defines an aperture 248 that receives andcaptures the valve body 224 and defines a particulate bore 250 and aliquid bore 252. The particulate bore 250 extends from the particulateport 227 to an aperture 248, and the liquid bore 252 similarly extendsfrom the liquid port 228 to the aperture 248. While the valve body 224is captured within the aperture 248 of the hub 226, the valve body 224is still free to rotate a clockwise direction, as indicated by arrow 53(see FIG. 1), toward the first position and counterclockwise directiontoward the second position.

To inhibit leakage between the hub 226 and the valve body 224 and intothe aperture 248, an exemplary embodiment of the hub 226 and the valvebody 224 are manufactured from one or more materials that fluidly sealagainst each other with the valve body 224 captured within the hub 226.For example, the hub 226 is manufactured from a first material that isrelatively hard, while the valve body 224 is manufactured from a secondmaterial that is relatively soft. As such, the valve body 224 is sizedrelative to the aperture 248 to be compressed therein for sealingagainst the hub 226. More particularly, the first material of the hub226 is polycarbonate, and the second material of the valve body 224 ispolypropylene. As such, the first and second material inhibit thevacuum, the particulate biomaterial, and the liquid biomaterial fromleaking into the aperture 248 and/or into the ambient environment.

FIG. 6A shows the apparatus 210 having the valve body 224 in the firstposition. The valve body 224 extends along the rotational axis 60 andincludes the distal opening 62 that opens into the vacuum port 230. Thevalve body 224 further defines a first conduit 264 that extends from thevacuum port 230 to the particulate bore 250 for fluid communication withthe particulate port 227. As such, the vacuum port 230 and theparticulate port 227 are fluidly connected only when the valve body 224is in the first position. As discussed above, the valve body 224 isalready in the first position and, as such, the vacuum port 230, thefirst conduit 264, the particulate bore 250, and the particulate port227 collectively define a first passage 265 extending from the vacuumdevice 18 to the particulate container 20. However, in the event thatthe valve body 224 is not in the first position, the hub 226 includes afirst abutment member (not shown) projecting distally toward the valvebody 224 that cooperates with a first stop surface (not shown) forpositioning the valve body 224. More particularly, the valve body 224rotates the clockwise direction 53 (see FIG. 1) until the first stopsurface (not shown) contacts the first abutment member (not shown) suchthat the first conduit 264 rotatably aligns to fluidly connect to theparticulate port 227 and define the first passage 265.

As discussed above in greater detail, the vacuum stroke 70 generates thevacuum, as indicated by arrows 72, and the pressure stroke 76 forreleasing the gas to the ambient environment. However, rather than theduckbill check valves 74, 80 shown in FIGS. 4A-4C, the valve 216 ofFIGS. 5-7 includes stainless steel ball check valves 274, 280. Inaddition, to complete the pressure stroke 76 without forcing the gasback into the particulate container 20, the valve body 224 furtherincludes a vent conduit 278 a extending from the first conduit 264 to anannular channel 278 b generally surrounding and at least partiallydefined by the valve body 224. The valve body 224 further includes acollar 279 further defining the annular channel 278 b. The collar 279also defines a plurality vent passages 278 c in fluid communicationbetween the annular channel 278 b and the ambient environment. Thesecond check valve 280 is positioned within the vent conduit 278 a torelease excess pressure from the first passage 265 to the annularchannel 278 b. From the annular channel 278 b, the gas vents to theambient environment through the plurality of vent passages 278 c so thatif the practitioner covers one or more of the vent passages 278 c duringthe medical procedure, the gas still may be forced to the ambientenvironment through one of the uncovered vent passages 278 c.

With respect to the second position, the hub 226 includes a secondabutment member 282 projecting distally toward the valve body 224 thatcooperates with a second stop surface 284. More particularly, the valvebody 224 rotates the counterclockwise direction until the second stopsurface 284 contacts the second abutment member 282, as indicated byarrow 85 of FIG. 6B. Accordingly, a second conduit 286 defined by thevalve body 224 rotatably aligns to fluidly connect the particulate port227 to the liquid port 228 and define a second passage 288 as shown inFIG. 6C.

The second passage 288 fluidly connects the particulate container 20 tothe liquid container 222 for releasing the desirable vacuum to theliquid container 222 and withdrawing the liquid biomaterial therefrom,as indicated by arrows 90, and similarly discussed above. Thereby, thevalve 216 is configured to hydrate the particulate biomaterial with theliquid biomaterial for forming the mixture of biomaterials for useduring the medical procedure.

With reference to FIGS. 8A-8C, a third embodiment of an apparatus 310for hydrating a particulate biomaterial with a liquid biomaterialincludes a valve 316 fluidly connected to the vacuum device 18, theparticulate container 20, and the liquid container 22. The particulatecontainer 20 holds the particulate biomaterial, while the liquidcontainer 22 holds the liquid biomaterial. With respect to the thirdembodiment of the apparatus 310, like numbers indicate like featuresdiscussed above and it will be appreciated that the above descriptionsimilarly applies to the apparatus 310.

The valve 316 includes a valve body 324 movably coupled with a hub 326and, as such, selectively moves between a first position and a secondposition. According to an exemplary embodiment, the hub 326 includes aparticulate port 327 and an opposing liquid port 328. In addition, thehub 326 includes a vacuum port 330 configured to removably connect tothe vacuum device 18 for generating a vacuum therein. The hub 326 alsodefines an aperture 348 that receives the valve body 324 slidablytherein. The valve body 324 is mounted to a bottom 325 via a biasingmember 329, such as a spring, for being biased in the second position.Specifically, the valve body 324 linearly translates, as indicated byarrow 353, from the second position to the first position within the hub326.

To inhibit leakage between the hub 326 and the valve body 324 and intothe aperture 348, an exemplary embodiment of the hub 326 includes anannular recess 354 a about the aperture 348 and positioned adjacent tothe valve body 324 for distal sealing above the particulate and liquidports 327, 328. The annular recess 354 a receives a seal 356 aconfigured to fluidly seal between the hub 326 and valve body 324 andinhibit leakage from the particulate and liquid ports 327, 328 throughthe vacuum port 330 and to the ambient environment. The valve body 324also includes additional annular recesses 354 b, 354 c positionedadjacent to both ends of the valve body 324 for further sealing. Theannular recess 354 b is adjacent to the biasing member 329 thatsimilarly receives another seal 356 b that is configured to fluidly sealbetween the hub 326 and the valve body 324 and inhibit the leakage fromthe particulate and liquid ports 327, 328 toward the bottom 325 of thevalve body 324. The annular recess 354 c is positioned adjacent to thevacuum port 330 and receives a seal 356 c for inhibiting leakage intothe vacuum port 330. Collectively, the seals 356 a, 356 b, 356 c inhibitthe vacuum, the particulate biomaterial, and the liquid biomaterial fromleaking into the aperture 348 and/or into the ambient environment.

As discussed briefly above, the valve body 324 is biased in the secondposition. However, by coupling the female coupling 44 of the vacuumdevice 18 to the vacuum port 330, the female coupling 44 engages thevalve body 324 and forces the valve body 324 linearly to the firstposition as shown in FIG. 8B for withdrawing the gas from theparticulate container 20. The hub 326 includes an abutment member 366projecting from the bottom 325 and surrounding the biasing member 329that cooperates with a stop surface 368 for positioning the valve body224 in the first position. More particularly, the valve body 324linearly translates into the aperture 348 until the stop surface 368contacts the abutment member 366.

With respect to FIG. 8B, the valve body 324 extends linearly along theaperture 348, and the hub 326 includes the distal opening 62 that opensinto the vacuum port 330. The valve body 324 defines a first conduit 364that extends from the vacuum port 330 to the particulate port 327. Assuch, the vacuum port 330 and the particulate port 327 are fluidlyconnected only when the valve body 324 is in the first position. In thefirst position, the vacuum port 330, the first conduit 364, and theparticulate port 327 collectively define a first passage 365 extendingfrom the vacuum device 18 to the particulate container 20.

As discussed above in greater detail, the vacuum stroke 70 generates thevacuum, as indicated by arrows 72. However, rather than the duckbillcheck valve 74 shown in FIGS. 4A-4C, the valve 316 of FIGS. 8A-8Cincludes the stainless steel ball check valve 274 discussed above. Whilethe third embodiment of the apparatus 310 does not include a secondcheck valve for venting gas, such as during the pressure stroke 76discussed above, it will be appreciated that such a check valve may beused with the apparatus 310, and the apparatus 310 is not intended to belimited to one check valve and/or one vacuum stroke 70.

Once the desirable vacuum is maintained within the particulate container20, the practitioner disconnects the vacuum device 18 from the vacuumport 330 to allow the biasing member 329 to linearly translate the valvebody 324 to the second position. In the second position, a secondconduit 386 defined by the valve body 324 linearly aligns to fluidlyconnect the particulate port 327 to the liquid port 328 and define asecond passage 388 as shown in FIG. 8C.

The second passage 388 fluidly connects the particulate container 20 tothe liquid container 22 for releasing the desirable vacuum to the liquidcontainer 22 and withdrawing the liquid biomaterial therefrom, asindicated by arrows 90, and similarly discussed above. Thereby, thevalve 316 is configured to hydrate the particulate biomaterial with theliquid biomaterial for forming the mixture of biomaterials for useduring the medical procedure.

In use, the practitioner removes the plungers 36 from the particulatecontainer 20 and liquid container 22 shown in FIGS. 1-3 and loads eachwith the particulate biomaterial and the liquid biomaterial,respectively, during a medical procedure. Alternatively one or both ofthe particulate and liquid containers 20, 22 may be preloaded with aparticular biomaterial and liquid biomaterial for the convenience of thepractitioner. In any case, the particulate and liquid containers 20, 22are each fluidly connected to the particulate and liquid ports 27, 28,respectively, via cooperating male and female couplings 42, 44. Whilethe following describes the method of hydrating the particulate andliquid biomaterial primarily with respect to the first embodiment of theapparatus 10, it will be appreciated that additional embodiments may besimilarly used.

The vacuum device 18, such as the syringe 32, is also fluidly connectedto vacuum port 30 by connecting the male coupling 42 of the vacuum port30 to the female coupling 44 of the vacuum device 18. According to anexemplary embodiment, the male and female couplings 42, 44 are male andfemale luer couplings 42, 44 that rotatably connect with the clockwisedirection 53 and rotatably disconnect with the counterclockwisedirection 85. Notably, the clockwise direction 53 for fluid connectionof the vacuum device 18 is also the direction for moving the valve body24 to the first position, and the counterclockwise direction 85 forfluid disconnection of the vacuum device 18 is also the direction formoving the valve body 24 to the second position. Accordingly, thepractitioner is able to direct the valve body 24 to the first and secondpositions while simultaneously fluidly connecting and disconnecting thevacuum device 18, respectively, for simplifying the medical procedure.

In the first position, the vacuum device 18 fluidly connects to theparticulate container 20 via the first passage 65, which is at leastpartially defined by the valve body 24. With respect to FIG. 4A and FIG.4B, the practitioner manipulates the plunger 36 of the vacuum device 18through the vacuum and pressure strokes 70, 76 as needed to generate thedesirable vacuum within the particulate container 20 and vent the gas tothe ambient environment as discussed above in greater detail. It will beappreciated, however, that the pressure stoke 76 is not necessary if thedesirable vacuum within the particulate container 20 is generated duringthe initial vacuum stroke 70.

Once the desirable vacuum is maintained within the particulate container20, the practitioner rotates the vacuum device 18 counterclockwise, asshown in FIG. 4B, to simultaneously disconnect the vacuum device 18 fromthe vacuum port 30 and rotate the valve body 24 to the second position,as shown in FIG. 4C. With respect to FIG. 4C, the first conduit 64fluidly disconnects from the particulate port 27 and the second conduit86 fluidly connects to the particulate port 27 to define the secondpassage 88. The second passage 88 fluidly connects the particulate andliquid containers 20, 22 in the second position to release the desirablevacuum within the particulate container 20 to the liquid container 22.The liquid biomaterial is thereby withdrawn from the liquid container 22and forced into the particulate container 20 with the particulatebiomaterial. Under the influence of the vacuum, the liquid biomaterialmore quickly and uniformly absorbs throughout the particulatebiomaterial to form a mixture of biomaterials. However, in the eventthat the liquid biomaterial fails to uniformly absorb throughout theparticulate biomaterial, the practitioner may also manipulate theplungers 36 of both the particulate and liquid containers 20, 22cooperatively to force the mixture of biomaterials back and forthbetween both containers 20, 22. In doing so, the mixture of biomaterialsis agitated by passing back and forth through the second passage 88 forblending the mixture of biomaterials uniformly.

The practitioner disconnects one or both of the particulate and liquidcontainers 20, 22 containing the mixture of biomaterials from the hub26. To dispense the mixture of biomaterials, the practitioner thenmanipulates the plunger 36 to force the mixture of biomaterials from thesyringe body 34. According to an exemplary embodiment, the mixture ofbiomaterials includes bone graft materials, and, as such, is dispensedonto an anatomical site of a patient during a medical procedure.

While the present invention has been illustrated by the description ofone or more embodiments thereof, and while the embodiments have beendescribed in considerable detail, they are not intended to restrict orin any way limit the scope of the appended claims to such detail. Thevarious features shown and described herein may be used alone or in anycombination. Additional advantages and modifications will readily appearto those skilled in the art. The invention in its broader aspects istherefore not limited to the specific details, representative apparatusand method and illustrative examples shown and described. Accordingly,departures may be from such details without departing from the scope ofthe general inventive concept.

What is claimed is:
 1. An apparatus for hydrating a particulatebiomaterial with a liquid biomaterial, the apparatus comprising: avacuum device configured to generate a vacuum therein; and a valve forwithdrawing a gas from the particulate biomaterial and introducing theliquid biomaterial to the particulate biomaterial, the valve comprising:a hub; a valve body movably coupled to said hub and configured toselectively move between a first position and a second position, saidvalve body at least partially defining a first passage and a secondpassage; a particulate port configured to fluidly connect to aparticulate container holding the particulate biomaterial therein; avacuum port configured to fluidly connect to said vacuum device suchthat said first passage fluidly connects said vacuum port to saidparticulate port when said valve body is in said first position forwithdrawing the gas from the particulate container, said vacuum port andsaid particulate port further defining said first passage when saidvalve body is in said first position; a liquid port configured tofluidly connect to a liquid container holding the liquid biomaterialtherein such that said second passage fluidly connects said liquid portto said particulate port when said valve body is in said second positionfor withdrawing the liquid biomaterial from the liquid container,through said second passage, and to the particulate container forhydrating the particulate biomaterial; and a first check valve providedwithin said valve body and configured to open under influence of thevacuum within said vacuum port for withdrawing the gas from saidparticulate container and further configured to close in an absence ofthe vacuum within said vacuum port to maintain a vacuum within saidparticulate container.
 2. The apparatus of claim 1 wherein said valvebody is rotatably coupled with said hub and configured to selectivelyrotate about a rotational axis between said first position and saidsecond position.
 3. The apparatus of claim 2 wherein said valve bodydefines said vacuum port, at least a portion of said vacuum port extendsparallel to said rotational axis, and said vacuum port is configured torotatably connect to said vacuum device in a first direction forrotatably disconnecting said vacuum device in a second directionopposite from said first direction.
 4. The apparatus of claim 3 whereinsaid valve body rotates in said second direction from said firstposition to said second position, and said vacuum port is configured torotatably disconnect from said vacuum device in said second directionand move said valve body from said first position to said secondposition while disconnecting said vacuum device therefrom.
 5. Theapparatus of claim 1 wherein said valve body is linearly coupled withsaid hub and configured to selectively translate between said firstposition and said second position.
 6. The apparatus of claim 1 furthercomprising: a second check valve in fluid communication with said firstpassage and an ambient environment, said second check valve configuredto close under influence of the vacuum within said vacuum port forwithdrawing the gas from the particulate container and configured opento the ambient environment under influence of a pressurized gas fordischarging the pressurized gas from said first passage and into theambient environment.
 7. The apparatus of claim 6 further comprising: aplurality of vent passages at least partially defined by at least one ofsaid hub and said valve body, said plurality of vent passages fluidlyconnected between said second check valve and the ambient environmentfor venting the pressurized gas to the ambient environment.
 8. Theapparatus of claim 1 wherein said vacuum device is a first syringeincluding a first syringe body and a first piston such that withdrawingsaid first piston within said first syringe body generates the vacuumwithin said first syringe body.
 9. The apparatus of claim 1 furthercomprising said particulate container.
 10. The apparatus of claim 9wherein said particulate container is a second syringe configured tohold the particulate biomaterial.
 11. The apparatus of claim 1 furthercomprising said liquid container.
 12. The apparatus of claim 11 whereinsaid liquid container is a third syringe configured to hold the liquidbiomaterial.
 13. A valve for withdrawing a gas from a particulatebiomaterial and introducing a liquid biomaterial to the particulatebiomaterial, the valve comprising: a hub; a valve body movably coupledto said hub and configured to selectively move between a first positionand a second position, said valve body at least partially defining afirst passage and a second passage; a particulate port configured tofluidly connect to a particulate container holding the particulatebiomaterial therein; a vacuum port configured to fluidly connect to avacuum device for generating a vacuum such that said first passagefluidly connects said vacuum port to said particulate port when saidvalve body is in said first position for withdrawing the gas from theparticulate container, said vacuum port and said particulate portfurther defining said first passage when said valve body is in saidfirst position; a liquid port configured to fluidly connect to a liquidcontainer holding the liquid biomaterial therein such that said secondpassage fluidly connects said liquid port to said particulate port whensaid valve body is in said second position for withdrawing the liquidbiomaterial from the liquid container, through said second passage, andto the particulate container for hydrating the particulate biomaterial;and a first check valve provided within said valve body and configuredto open under influence of the vacuum within said vacuum port forwithdrawing the gas from said particulate container and furtherconfigured to close in an absence of the vacuum within said vacuum portto maintain a vacuum within said particulate container.
 14. The valve ofclaim 13 wherein said valve body is rotatably coupled with said hub andconfigured to selectively rotate about a rotational axis between saidfirst position and said second position.
 15. The valve of claim 14wherein said valve body defines said vacuum port, at least a portion ofsaid vacuum port extends parallel to said rotational axis, and saidvacuum port is configured to rotatably connect to the vacuum device in afirst direction for rotatably disconnecting said vacuum device in asecond direction opposite from said first direction.
 16. The valve ofclaim 15 wherein said valve body rotates in said second direction fromsaid first position to said second position, and said vacuum port isconfigured to rotatably disconnect from the vacuum device in said seconddirection and move said valve body from said first position to saidsecond position while disconnecting the vacuum device therefrom.
 17. Thevalve of claim 13 wherein said valve body is linearly coupled with saidhub and configured to selectively translate between said first positionand said second position.
 18. The valve of claim 13 further comprising:a second check valve in fluid communication with said first passage andan ambient environment, said second check valve configured to closeunder influence of the vacuum within said vacuum port for withdrawingthe gas from the particulate container and configured open to theambient environment under influence of a pressurized gas for dischargingthe pressurized gas from said first passage and into the ambientenvironment.
 19. The valve of claim 18 further comprising: a pluralityof vent passages at least partially defined by at least one of said huband said valve body, said plurality of vent passages fluidly connectedbetween said second check valve and the ambient environment for ventingthe pressurized gas to the ambient environment.